VANCOUVER, BC / October 21, 2025 / (“BioNxt” or the “Company”) (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT), a bioscience innovator focused on advanced drug delivery technologies, is pleased to announce it has initiated a crucial large-mass animal bioequivalence study for BNT23001, its leading sublingual Cladribine formulation designed for multiple sclerosis (“MS”) treatment. This represents the final animal study intended to establish dosing parameters for the Company’s human comparative bioequivalence study, which is scheduled for early 2026.
“The Company has previously confirmed dosage bioequivalence in small-mass animals (under 20kgs); however, a study involving large-mass animals (over 40kgs) will provide valuable insights into the optimal sublingual drug quantity for human use,” stated Hugh Rogers, BioNxt’s CEO. “This large-mass animal study is expected to enhance the precision of our formulation for the human study and is structured to yield comparative drug absorption data between the Company’s sublingual formulation and the reference brand tablet formulation. Determining the ideal drug load per dose and assessing potential super bioavailability are vital pieces of information that will guide the ultimate clinical planning for our forthcoming comparative human bioequivalence study.”
The large-mass animal crossover bioequivalence study is slated to begin within the next two to three weeks and will span 15 days. Completion of the study is anticipated in November, with results expected to be available in December.
BNT23001 is an orally dissolving thin-film formulation of cladribine, a recognized immunomodulatory compound utilized in the treatment of MS. Delivered sublingually, the formulation aims for improved bioavailability, a quicker onset of action, and better patient adherence, particularly benefiting individuals with dysphagia or those seeking non-invasive alternatives to conventional tablets or injections. As previously reported, preclinical studies have demonstrated high absorption rates, bioequivalence to existing oral therapies, and no signs of toxicity.
The process of patent nationalization is currently in progress across key global markets, including the European Union, Canada, Australia, Eurasia, New Zealand, and Japan, in addition to a Track One priority filing in the United States. Both the European Patent Office and the Eurasian Patent Office have issued favorable communications, including notices indicating intentions to grant. The formulation’s novelty, inventive step, and industrial applicability have been fully acknowledged.
About BioNxt Solutions Inc.
BioNxt Solutions Inc. is a bioscience innovator specializing in advanced drug delivery platforms, diagnostic screening systems, and the development of active pharmaceutical ingredients. Its proprietary technologies encompass sublingual thin films, transdermal patches, oral tablets, and a novel targeted chemotherapy platform designed to deliver cancer drugs directly to tumors while mitigating side effects.
With research and development activities spanning North America and Europe, BioNxt is actively pursuing regulatory approvals and commercialization efforts, primarily concentrating on European markets. BioNxt is dedicated to enhancing healthcare by providing precise, patient-focused solutions that improve treatment outcomes globally.
BioNxt is listed on the Canadian Securities Exchange under the symbol BNXT, on OTC Markets as BNXTF, and trades in Germany under WKN: A3D1K3. To discover more about BioNxt, please visit .
Investor Relations & Media Contact
Hugh Rogers, Co-Founder, CEO and Director
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Cautionary Statement Regarding “Forward-Looking” Information
This press release contains “forward-looking information” and “forward-looking statements” as defined by applicable Canadian securities laws (collectively referred to as “forward-looking information”). Such information may include, but is not limited to, statements concerning: the anticipated granting, scope, and timing of European, Eurasian, and other international patent rights; the Company’s plans for additional national filings; the development, clinical assessment, regulatory approval, and commercialization of the Company’s Cladribine sublingual thin-film (BNT23001) for multiple sclerosis; the strategic importance of intellectual property protection; the timing, expenses, and results of preclinical and clinical studies; and the potential applicability of BioNxt’s sublingual thin-film drug delivery platform across various therapeutic areas.
Forward-looking information is based on management’s current expectations, assumptions, estimates, and projections as of the date of this press release. These statements are subject to inherent risks and uncertainties, many of which are beyond the Company’s control, that could lead to actual results, performance, or achievements differing significantly from those expressed or implied. These risks and uncertainties include, but are not limited to: the outcomes of patent examination and prosecution processes; changes in regulatory requirements or legal frameworks; the results, timing, and costs associated with preclinical and clinical studies; the scalability and reproducibility of manufacturing processes; the availability of strategic partnerships and funding; and broader economic, financial, or geopolitical factors.
Readers are advised not to place undue reliance on forward-looking information. While the Company believes the expectations and assumptions underpinning such information are reasonable, there is no guarantee that they will prove to be accurate. Except as mandated by applicable securities laws, BioNxt assumes no obligation to update or revise any forward-looking information, whether as a result of new information, future events, or otherwise.